EU Chemicals Strategy for Sustainability, Green New Deal

On October 14, 2020, the European Commission published a policy document Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (hereinafter, “CSS”) to update the EU’s chemicals management requirements and to advance towards the goal of zero pollution articulated in the European Green Deal published in December 2019.

The commission recommends significant changes to the EU CLP and REACH regulations as the foundation for policy changes, generally advancing the commission’s goal of zero environmental chemical pollution. As a result, companies placing products on the EU market will see significant changes in how products are evaluated for safety with increased restrictions to market access. Companies may be required to update labels based on new hazard classes.

Note that there is an emphasis on responding to an identified hazard, rather than the risk of exposure. These policy changes clearly embrace the “Precautionary Principle”. The commission also plans to implement a hazard-based approach at the global scale, by introducing new hazard classes into the GHS and seeking to phase-out chemical groups and hazard classes through international conventions and agreements.

As of April 2024, the Commission has taken several steps to advance the CSS by finalizing changes to the EU CLP Regulation (Classification, Labeling and Packaging Regulation, Regulation (EC) No 1272/2008), working towards harmonizing regulatory chemical databases, advancing sustainable products requirements and developing procedures for chemical restrictions under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC 1907/2006).

In December 2023, the European Council and the Commission finalized changes to the EU CLP, affecting classification and labelling of chemicals, including labeling strategies to better convey hazards to downstream users. The changes will require companies to update labels with new information elements and font size requirements. Revisions allow fold-out labels and digital labeling in limited circumstances, provided information on a digital label is not critical to protection of health, safety or the environment.

Amendments to the CLP also prioritize new hazard classes for harmonized classification of chemicals while empowering the European Commission to initiate classification of chemicals. Previously only member states and industry could initiate classification. The change is expected to result in faster classification of substances or groups of substances, a first stage to restricting those substances under REACH.

Changes to the CLP also include new requirements for classifying mixtures. The CLP generally allows classification of mixtures based on classification of substances in the mixture. Amendments now provide new classification requirements for mixtures of carcinogens, endocrine disruptors, persistent chemicals, mobile chemicals and bioaccumulating chemicals. Mixtures containing such chemicals must be tested and classified as a mixture, rather than classifying based on chemical components.

Revisions to the CLP require increased incorporation of NAMs (New Approach Methodologies). These are test methods for chemical classification that reduce reliance on animal testing. The CLP emphasizes importance of NAMs for new classifications such as endocrine disruptors, neurotoxicity and immunotoxicity. These will also be incorporated into REACH. Industry has concerns about the accuracy of NAMs when compared to conventional animal testing.

The Commission will resume discussion regarding changes to REACH later in 2024. The EU Commission has temporarily put discussions on hold due to upcoming parliamentary elections. CEPE has developed an approach to Alternatives Assessment that’s received some attention. CEPA proposes that an Alternative Assessment should be early in the evaluation process to avoid regrettable substitution. The CEPE proposal establishes hazard criteria and a process that ECHA would oversee with input from all stakeholder.

Another key element to modifying the REACH restriction process involves incorporating a MAF (mixture assessment factor) into REACH registration requirements. MAF is a way of estimating cumulative effects of exposure to multiple chemicals via different routes of exposure. The MAF would be included for registration of substances, and it can be used to assess the risks of using a chemical in various downstream mixtures. Industry and some member states have concerns about utility and accuracy of adopting a MAF. Industry is proposing that it should be limited to certain consumer products, since it could interfere with industrial safety methods. A MAF should have a lengthy transition period. MAF should be one factor in a broad risk assessment, rather than relying on the MAF as an indicator of risk.

The Commission prioritized finalizing the EU Ecodesign for Sustainable Products law, aiming to finalize requirements later in 2024. This will initiate evaluation of paints and coatings against sustainable design criteria, with a focus on preventing microplastic pollution. The law requires a panel to develop product-specific ecodesign criteria for products based on principles stipulated in the law. The law also promotes use of a Digital Product Passport to provide information about products’ environmental sustainability.

Prior CSS Implementation Activities:

In December 2022, the Commission adopted the following new hazard classes into the EU Classification, Labeling and Packaging Regulation:
• endocrine disruptors (ED) for human health or the environment,
• persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB),
• persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM).

The Commission will campaign for adoption into the UN GHS while also encouraging countries to independently adopt through bilateral agreements with Europe. The Commission also introduced a related proposal that would establish phase-in times within Europe and hazard communication requirements.

A key element of the Chemical Strategy for Sustainability is establishing a uniform understanding of safety and sustainability at the research and development phase. Towards this goal, the Commission published draft “Safe and Sustainable by Design” recommendations that would guide reformulation and initial product development for chemicals once finalized. The Commission is providing a two-year test period for pilot implementation and further refinement.

In a separate proposal in March 2023, the Commission proposed adoption of eco-design criteria for sustainable products, referred to as ESPR. The ESPR would establish basic principles related to a variety of sustainability goals including recycled content, energy efficiency and carbon footprint. Once finalized, the Commission intends to select products to undergo more detailed evaluation followed by publication of product-specific sustainability criteria. The commission has proposed paints, varnishes, polymers and plastics be included in the first batch of products.

In December 2022, the Commission published a study to advance recommendations for Key Performance Indicators for industry transitioning to sustainable chemicals. KPI’s will establish how European companies are moving towards sustainable chemicals more generally. However, the report is based on data the commission collected prior to developing Safe and Sustainable by Design criteria, so they do not reflect transition to meet this criteria. The following indicators are recommended to be used for KPIs to monitor the transition to the production of safe and sustainable chemicals. In some cases, recommendations to modify the indicators have been made:

• Consumption of chemicals by hazard class (ENV_CHMHAZ), Eurostat
• Modification of this indicator to not exclude exports is recommended. The current hazard classification-based monitoring system could be improved to focus on hazards targeted by the CSS (e.g., substances of concern are those with chronic effects for human health and the environment).
• Greenhouse gas (GHG) emissions by source sector (env_air_gge), Eurostat
• Total energy consumption in the EU chemical industry by source, Eurostat
• Total hazardous and non-hazardous waste in the EU chemicals industry, EEA / E-PRTR
• Industrial pollutant releases to water in Europe, E-PRTR / EEA.

The Commission assessed the first draft of KPI’s as insufficient to fully monitor the transition to safe and sustainable chemicals. For example, they cover only material consumption as a reflection of circularity, hazardousness, GHG emissions, and energy consumption. The Commission recently recommended the following new indicators:
• Production value/market share of safe and sustainable chemicals
• Number of safe and sustainable chemicals on the market
• Number of substances of concern on the market
• Production and consumption of chemicals by type (including safe and sustainable chemicals and substances of concern)
• Carbon intensity (carbon consumption for energy and feedstock production per unit chemical product)
• Eco-innovation index for the chemical industry (chemical innovation resulting in progress towards sustainable development)
• Research and innovation spending on safe and sustainable chemicals.

Legislators are further considering changes to hazard communication to more clearly convey information to both consumers and workers. This includes changes to classification mixtures, timelines for harmonized classifications using new hazard classes, formatting changes to labels and guidelines for digital labeling. On September 11, 2023, the European Parliament issued a position paper regarding these issues, in response to the European Commission’s position paper published in July 2023. The two positions will be reconciled to develop a final proposal.

The European Commission is further considering alternatives assessment procedure to inform the GRA (Generic Risk Assessment) approach. The GRA is designed to restrict chemicals based on hazard properties. Similarly, the European Commission is also commissioning a study designed to evaluate regulatory options to encourage substitution. The commiss

ACA Action

ACA will be monitoring changes closely and will convey related information to ACA’s Product Stewardship Committee and the World Coatings Council to seek member comment. ACA, through the World Coatings Council, is coordinating with CEPE (the European Council of the Paint, Printing Ink and Artists‘ Colours Industry) and CEFIC (European Chemicals Industry Counsel) towards developing position papers. CEPE and CEFIC are also meeting with ECHA representatives to discuss industry positions and key concepts.